Quality IT Systems Specialist

Catalent Pharma Solutions
Unspecified Highly Competitive
07 Oct 2016
19 Oct 2016
Contract Type
Here at Catalent Bathgate, the patient comes first. Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products across the UK and Europe based in Bathgate, Scotland. We are currently looking to recruiting for a creative and innovative Quality Compliance Specialist to join the QA team at this exciting time of continued and sustained growth within the Pharmaceutical industry. Our Global Regulatory Compliance team is responsible for implementing and sustaining a world class Quality Management System (QMS) and ensuring that Catalent Pharma Solutions meets all customer and regulatory agency GMP/Regulatory requirements and expectations. The Catalent QMS establishes the requirements for how Catalent Pharma Solutions complies with all applicable regulations and guidance worldwide, including but not limited to, good manufacturing practice/quality systems requirements of the US Food and Drug Administration, European, South American, Asian (including Japanese and Chinese) and Australian agencies where Catalent sites are based and other International and/or local health authorities. In this role you will be responsible for supporting the infrastructure and processes for GMP/Regulatory compliance within Catalent Pharma Solutions, with particular emphasis on Quality oversight associated with IT systems Project support across the laboratory, manufacturing and packing business units. Your role will see you provide IT/CSV quality oversight to global GMP projects including CDS, MES, LIMS, QMS and Serialization. The role will include site compliance audits, supplier audits, quality agreements, change control, global data integrity and other IT quality initiatives. As the successful candidate you will join our team of dedicated professionals to establish and maintain world class, regulatory compliant systems that support Catalent as the premier provider of pharmaceutical services. Knowledge, Skills and Abilities Demonstrated experience and excellent knowledge of applicable CSV and IT regulations including the US FDA CFR’s, EU, ICH, as well as the GAMP guidance. Working knowledge of Project Management and Software Development Life Cycles. Familiarity with computer infrastructure, servers, workstations, operating systems and data base management systems. Familiarity with computerized pharmaceutical GMP systems such as LIMS, CDS, BMS, Metrology, Analytical Instrumentation, Manufacturing and Packaging systems and associated vendors. Appropriate leadership skills and behaviors aligned with Catalent competencies and values. Excellent written and verbal communication skills as well as good presentation skills. Ability to coordinate and work within cross-functional teams. Must demonstrate organizational skills and be able to interact with personnel at all levels within the organization from a variety of cultural backgrounds. Must be a self-starter, able to work independently in a remote none office based role and have ability to multi-task under strict deadlines. Detail orientated with ability to accomplish objectives through clear thinking and strong personal organizations skills. Education and experience Degree or equivalent in relevant discipline is required Educational qualifications associated with IT and/or pharmaceutical science would be an advantage (i.e. MIS, CIS, Chemistry, etc) 5 to 10 years within the Pharmaceutical or related industry, which includes a minimum of 5 years in an IT, Quality, Regulatory and or Operations (Laboratory, manufacturing, packaging) role is required Advanced communication skills in the English Language is required About Catalent Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent is headquartered in Somerset, N.J. For more information, visit our website. More products. Better treatments. Reliably supplied.™ Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to Jobscatalent This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. This job was originally posted as www.totaljobs.com/job/66820738